In general, an unapproved medical device may be used only on human subjects when the device is under clinical investigation and when used by investigators participating in a clinical trial. Section 561 of the Act, however, recognizes that there may be circumstances under which a health care provider may wish to use an unapproved device to save the life of a patient or to prevent irreversible morbidity when there exists no other alternative therapy. For investigational devices under an IDE, the IDE regulation permits deviations from the investigational plan without prior approval when necessary to protect the life or physical well-being of a subject in an emergency. (See 21 CFR 812.35(a)). A physician may treat a patient with an unapproved medical device in an emergency situation if he/she concludes that:
• The patient has a life-threatening condition that needs immediate treatment;
• No generally acceptable alternative treatment for the condition exists; and
• Because of the immediate need to use the device, there is no time to use existing procedures to get FDA approval for the use.
FDA expects the physician to make the determination that the patient's circumstances meet the above criteria, to assess the potential for benefit from the use of the unapproved device, and to have substantial reason to believe that benefits will exist. In the event that a device is used in circumstances meeting the criteria listed above, the physician should follow as many of the patient protection procedures listed below as possible.
• Informed consent from the patient or a legal representative;
• Clearance from the institution as specified by their policies;
• Concurrence of the IRB chairperson;
• An assessment from a physician who is not participating in the study; and
• Authorization from the IDE sponsor, if an IDE exists for the device.
While prior approval for shipment or emergency use of the investigational device is not required, the use must be reported to FDA by the IDE sponsor within 5 working days from the time the sponsor learns of the use. 21 CFR 812.35(a)(2) and 812.150(a)(4). The report should contain a summary of the conditions constituting the emergency, patient outcome information, and the patient protection measures that were followed. If no IDE exists, the physician should follow the above procedures and report the emergency use to CDRH or CBER.
For additional information on the procedures physicians and IRBs should follow in an emergency use situation, please see Chapter III Expanded Access to Unapproved Devices of the guidance entitled, “IDE Policies and Procedures.